Influenza Vaccine in HIV Study

December 15, 2015 updated by: Prof Stephen Kent, University of Melbourne

A Comparison of Immune Responses to the Licensed Trivalent Inactivated Influenza Vaccine in HIV-positive and HIV-negative Subjects

The aims of this study are:

  1. to investigate if HIV infection alters the antibody responses to influenza and
  2. to assess the ability of licensed influenza vaccine to induce functional non-neutralising antibodies in HIV-infected and HIV-uninfected subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

57

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects are recruited from two sites in Melbourne, Australia:

  • Melbourne Sexual Health Centre (HIV-positive and HIV-negative subjects)
  • The University of Melbourne at the Peter Doherty Institute for Infection and Immunity (HIV-negative subjects only)

Description

Inclusion Criteria:

  • HIV-1 positive by licensed diagnostic test (for HIV-positive group only)
  • Planning to receive the seasonal influenza vaccine outside the study
  • Provision of written informed consent

Exclusion Criteria:

  • Previous allergy to influenza vaccination
  • Pregnancy or planning to become pregnant
  • Unwilling or unable to provide blood samples

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIV-negative
Biological: 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)
Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.
HIV-positive
Biological: 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)
Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-influenza antibody responses in plasma with Fc-mediated functions
Time Frame: Four weeks after influenza vaccination
Four weeks after influenza vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Melbourne

Investigators

  • Principal Investigator: Stephen Kent, Professor, University of Melbourne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Estimate)

December 16, 2015

Last Update Submitted That Met QC Criteria

December 15, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kent001
  • AISRF08020 (Other Grant/Funding Number: The Australia-India Strategic Research Fund)
  • 1041832, 1042634, 1052979 (Other Grant/Funding Number: The Australian National Health and Medical Research Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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